BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    0.89mm Intra-Vitreal Pencil

    DI: 05055272707671 · Model: 2509-P-8003 · KEELER LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    0.89mm Intra-Vitreal Pencil
    Primary DI
    05055272707671
    Version / Model
    2509-P-8003
    Company Name
    KEELER LIMITED
    Labeler DUNS
    210164398
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-16
    Public Version
    4
    Public Version Date
    2023-02-06
    Public Version Status
    Update
    Public Device Record Key
    d67383ab-f743-451b-97db-af2d9d6132ae

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HRN Unit, Cryophthalmic, Ac-Powered

    GMDN Terms

    Code Name
    46052 Ophthalmic cryosurgical system, electronic

    Identifiers

    Type ID
    Primary 05055272707671